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Abstract:

A nitric oxide delivery device including a valve assembly, a control
module and a gas delivery mechanism is described. An exemplary gas
delivery device includes a valve assembly with a valve and circuit
including a memory, a processor and a transceiver in communication with
the memory. The memory may include gas data such as gas identification,
gas expiration and gas concentration. The transceiver on the circuit of
the valve assembly may send wireless optical line-of-sight signals to
communicate the gas data to a control module. Exemplary gas delivery
mechanisms include a ventilator and a breathing circuit. Methods of
administering gases containing nitric oxide are also described.

Claims:

1. A nitric oxide delivery device comprising: a control module to deliver
a gas comprising NO to a patient in an amount effective to treat or
prevent hypoxic respiratory failure; and a valve assembly to deliver the
gas comprising NO from a gas container containing the gas comprising NO
to the control module, the valve assembly comprising: a valve attachable
to the gas container containing the gas comprising NO, the valve
including an inlet and an outlet in fluid communication and a valve
actuator to open or close the valve to allow the gas comprising NO
through the valve to the control module; and a circuit supported within
the valve assembly and disposed between the actuator and a cap, the
circuit including: a valve memory to store gas data comprising gas
concentration in the gas container and a valve processor and a valve
transceiver in communication with the valve memory to send wireless
optical line-of-sight signals to communicate the gas data to the control
module.

2. The nitric oxide delivery device of claim 1, where in the valve
assembly further comprises a data input disposed on the actuator and in
communication with said valve memory, to permit a user to enter the gas
data into the valve memory.

3. The nitric oxide delivery device of claim 2, wherein the gas data is
provided in a bar code disposed on the gas container and is entered into
the data input by a user-operated scanning device in communication with
the data input.

4. The nitric oxide delivery device of claim 1, wherein the valve
comprises a power source; and the valve transceiver periodically sends
the wireless optical line-of-sight signals to the control module, wherein
the signals are interrupted by a duration of time at which no signal is
sent.

5. The nitric oxide delivery device of claim 4, wherein the duration of
time at which no signal is sent comprises about 10 seconds.

6. The nitric oxide delivery device of claim 1, wherein the control
module comprises: a CPU transceiver to receive line-of-sight signals from
the valve transceiver; a CPU in communication with the CPU transceiver
and including a CPU memory; and a display to enter patient information
into the CPU memory, wherein the valve transceiver communicates the gas
data comprising gas concentration to the CPU transceiver for storage in
the CPU memory, and wherein the CPU compares the patient information
entered into the CPU memory via the display and the gas concentration
from the valve transceiver.

7. The nitric oxide delivery device of claim 6, wherein the valve
comprises a timer including a calendar timer and an event timer, wherein
the valve memory stores the date and time of opening and closing of the
valve and the duration of time that the valve is open and the valve
transceiver communicates the date and time of opening and closing of the
valve to the CPU transceiver for storage in the CPU memory.

8. The nitric oxide delivery device of claim 6, wherein the CPU comprises
an alarm that is triggered when the patient information entered into the
CPU memory and the gas data from the valve transceiver do not match.

9. The nitric oxide delivery device of claim 6, wherein the CPU memory
comprises instructions that cause the CPU processor to: receive gas data
comprising gas concentration from the valve via a wireless optical
line-of-sight signal with the valve connected to the gas container
containing gas comprising NO; compare the gas data with user-inputted
patient information; coordinate delivery of therapy to the patient with a
medical device via the wireless optical line-of-sight signal between the
CPU transceiver and the valve transceiver; select a therapy for delivery
to a patient based on the received patient information; and control
delivery of the selected therapy to the patient.

10. The nitric oxide delivery device of claim 9, wherein the memory
further comprises instructions that cause the CPU processor to: receive a
first valve status selected from a first open position and a first closed
position from a first valve via a first wireless optical line-of-sight
signal with the first valve connected to a first gas container; receive a
second valve status selected from a second open position and a second
closed position from a second valve via a second wireless optical
line-of-sight signal with the second valve connected to a second gas
container; compare the first valve status and the second valve status;
and emit an alarm if the first valve status comprises the first open
position and the second valve status comprises the second open position.

11. The nitric oxide delivery device of claim 10, wherein the memory
further comprises instructions that causes the CPU processor to:
terminate delivery of therapy if the first valve status comprises the
first open position and the second valve status comprises the second open
position.

12. A method for treating or preventing hypoxic respiratory failure in a
patient, the method comprising: providing the nitric oxide delivery
device of claim 6; establishing communication between the valve
transceiver and the CPU transceiver and communicating the gas data from
the valve transceiver to the CPU; comparing the gas data communicated
from the valve transceiver with patient information stored within the CPU
memory; and delivering the gas comprising NO to the patient in an amount
effective to treat or prevent hypoxic respiratory failure.

13. The method of claim 12, further comprising ceasing delivery of the
gas comprising NO to the patient based on the comparison of the gas data
and the patient information.

14. The method of claim 12, further comprising emitting an alert based on
the comparison of the gas data and the patient information.

15. The method of claim 12, further comprising entering the gas data into
the valve memory.

16. The method of claim 12, further comprising entering the patient
information into the CPU memory.

Description:

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part application of U.S.
patent application Ser. No. 13/509,873 filed on May 15, 2012, which is
the National Phase entry of PCT/US2011/020319, filed Jan. 6, 2011, the
entire content of which are incorporated herein by reference in their
entirety.

TECHNICAL FIELD

[0002] Embodiments of the present invention relate to gas delivery device
for use in a gas delivery system for administering therapy gas and
methods of administering therapy gas.

BACKGROUND

[0003] Certain medical treatments include the use of gases that are
inhaled by the patient. Gas delivery devices are often utilized by
hospitals to deliver the necessary gas to patients in need. It is
important when administering gas therapy to these patients to verify the
correct type of gas and the correct concentration are being used. It is
also important to verify dosage information and administration.

[0004] Known gas delivery devices may include a computerized system for
tracking patient information, including information regarding the type of
gas therapy, concentration of gas to be administered and dosage
information for a particular patient. However, these computerized systems
often do not communicate with other components of gas delivery devices,
for example, the valve that controls the flow of the gas to the
computerized system and/or ventilator for administration to the patient.
In addition, in known systems, the amount of gas utilized by a single
patient is often difficult or impossible to discern, leading to possible
overbilling for usage.

[0005] There is a need for a gas delivery device that integrates a
computerized system to ensure that patient information contained within
the computerized system matches the gas that is to be delivered by the
gas delivery device. There is also a need for such an integrated device
that does not rely on repeated manual set-ups or connections and which
can also track individual patient usage accurately and simply.

SUMMARY

[0006] Aspects of the present invention pertain to a gas delivery device
that may be utilized with a gas delivery system and methods for
administering therapy gas to a patient. The therapy gas may comprise
nitric oxide (NO). One or more embodiments of the gas delivery devices
described herein may include a valve and a circuit with a valve memory in
communication with a valve processor and a valve transceiver. One or more
embodiments of the gas delivery systems described herein incorporate the
gas delivery devices described herein with a control module including a
control processing unit (CPU) in communication with a CPU memory and CPU
transceiver. As will be described herein, the valve transceiver and the
CPU transceiver may be in communication such that information or data
from the valve memory and the CPU memory may be communicated to one
another. The information communicated between the valve memory and the
CPU memory may be utilized for selecting a therapy for delivery to a
patient and controlling delivery of the selected therapy to the patient.
The gas delivery devices and systems described herein may be utilized
with medical devices such as ventilators and the like to delivery gas to
a patient.

[0007] A first aspect of the present invention pertains to a gas delivery
device. In one or more embodiments, the gas delivery device administers
therapy gas from a gas source containing NO under the control of a
control module. The control module may deliver the gas comprising NO to a
patient in an amount effective to treat and/or prevent hypoxic
respiratory failure and/or pulmonary hypertension. In one variant, the
gas delivery device may include a valve attachable to the gas source and
a circuit. The valve may include an inlet and an outlet in fluid
communication and a valve actuator to open and close the valve to allow
the gas to flow through the valve to a control module. The circuit of one
or more embodiments includes a memory, a processor and a transceiver in
communication with the memory to send wireless optical line-of-sight
signals to communicate information stored or retained within the memory
to the control module that controls gas delivery to a subject. In one or
more alternative embodiments, the signals to communicate information
stored or retained within the memory to the control module that controls
gas delivery to a subject may be communicated via a wire. Examples of
such wired signals may incorporate or utilize an optical cable, wired
pair and/or coaxial cable. The circuit may include a memory to store gas
data, which may include one or more of gas identification, gas expiration
date and gas concentration. The transceiver may communicate to send the
gas data to the control module via wireless optical line-of-sight
signals.

[0008] In one or more embodiments, the valve may include a data input in
communication with said memory, to permit a user to enter the gas data
into the memory. The gas data may be provided in a bar code that may be
disposed on the gas source. In such embodiments, the gas data may be
entered into the data input of the valve for storage in the memory by a
user-operated scanning device in communication with the data input.
Specifically, the user may scan the bar code to communicate the gas data
stored therein to the valve memory via the data input.

[0009] In one or more embodiments, the valve may include a power source.
In such embodiments, the power source may include a battery or other
portable power source. In one or more embodiments, the valve transceiver
may periodically send the wireless optical line-of-sight signals to the
control module, wherein the signals are interrupted by a duration of time
at which no signal is sent. In one or more specific embodiments, the
duration of time at which no signal is sent comprises about 10 seconds.

[0010] A second aspect of the present invention pertains to a gas delivery
device, as described herein, and a control module in fluid communication
with the outlet of the valve of the gas delivery device and with a gas
delivery mechanism, such as a ventilator. In one or more embodiments, the
control module may include a CPU transceiver to receive line-of-sight
signals from the transceiver and a CPU in communication with the CPU
transceiver. The CPU carries out the instructions of a computer program
or algorithm. As used herein the phrase "wireless optical line-of-sight
signal" includes infrared signal and other signals that require a
transmitter and receiver or two transceivers to be in aligned such that
the signal may be transmitted in a straight line. The CPU may include a
CPU memory that stores the gas data that is communicated by the valve
transceiver of the gas delivery device to the CPU transceiver.

[0011] In one or more embodiments, the gas delivery system may incorporate
a valve with a timer including a calendar timer and an event timer for
determining or marking the date and time that the valve is opened and
closed and the duration of time the valve is opened. In such embodiments,
the valve memory stores the date and time of opening and closing of the
valve and the duration of time that the valve is open and the valve
transceiver communicates the date and time of opening and closing of the
valve to the CPU transceiver for storage in the CPU memory.

[0012] In one or more variants, the gas delivery system may incorporate a
control module that further includes an input means to enter patient
information into the CPU memory. The control module may also have a real
time clock built into the CPU module such that the control module knows
what the current time and date is and can compare that to the expiration
date stored in the gas delivery device. If the expiration date is passed
the current date then the control module can cause an alarm and not
deliver drug to the patient. When the term "patient information" is used,
it is meant to include both patient information entered by the user and
information that is set during manufacturing, such as the gas
identification and the gas concentration that the control module is setup
to deliver. The control module may also include a display. In one or more
embodiments, the display incorporates an input means for entering patient
information into the CPU memory. In one or more embodiments, the CPU of
the control module compares the patient information entered into the CPU
memory via the input means and the gas data from the transceiver. The CPU
or control module may include comprises an alarm that is triggered when
the patient information entered into the CPU memory and the gas data from
the transceiver do not match or conflict. As used herein the phrase "do
not match," includes the phrase "are not identical," "are not
substantially identical," "do conflict" and/or "do substantially
conflict." The CPU determines whether the patient information and
additional data, or other data set matches by performing a matching
algorithm which includes criteria for establishing whether one set of
data (i.e. patient information) and another set of data match. The
algorithm may be configured to determine a match where every parameter of
the data sets match or selected parameters of the data sets match. The
algorithm may be configured to include a margin of error. For example,
where the patient information require a gas concentration of 800 ppm, and
the additional data includes a gas concentration of 805 ppm, the
algorithm may be configured to include a margin of error of ±5 ppm
such it determines that the patient information and the additional data
match. It will be understood that determining whether the patient
information and additional data match will vary depending on the
circumstances, such as variables in measuring gas concentration due to
temperature and pressure considerations.

[0013] A third aspect of the present invention pertains to a control
module memory comprising instructions that cause a control module
processor to receive gas data from a valve via a wireless optical
line-of-sight signal. The valve may be connected to a gas source
containing NO and may include a memory for storing the gas data. The
control module memory may include instructions that cause the control
module processor to compare the gas data with user-inputted patient
information. The user-inputted patient information may be stored within
the control module memory. Gas data may be selected from one or more of
gas identification, gas expiration date and gas concentration. In one or
more embodiments, the control module memory may include instructions to
cause the control module processor to coordinate delivery of therapy to
the patient with a medical device, such as a ventilator and the like for
delivering gas to a patient, via the wireless optical line-of-sight
signal. The control module memory may also include instructions to cause
the control module processor to select a therapy for delivery to a
patient based on the received patient information and control delivery of
the selected therapy to the patient.

[0014] In one or more embodiments, the memory may include instructions to
cause the processor to detect the presence of more than one valve and
whether more than one valve is open at the same time. In accordance with
one or more specific embodiments, the memory includes instructions to
cause the processor to receive a first valve status selected from a first
open position and a first closed position from a first valve via a first
wireless optical line-of-sight signal with the first valve connected to a
first gas source, receive a second valve status selected from a second
open position and a second closed position from a second valve via a
second wireless optical line-of-sight signal with the second valve
connected to a second gas source, compare the first valve status and the
second valve status, and emit an alarm if the first valve status
comprises the first open position and the second valve status comprises
the second open position. In one or more alternative embodiments, the
first valve status and the second valve status may be communicated to the
processor via a single wireless optical line-of-sight signal, instead of
separate wireless optical line-of-sight signals. In a more specific
embodiment, the memory of one or more embodiments may include
instructions to cause the processor to terminate delivery of therapy if
the first valve status comprises the first open position and the second
valve status comprises the second open position.

[0015] In one or more embodiments, the memory may include instructions to
cause the processor to emit an alarm when a desired dose has been
delivered through a valve. In such embodiments, the processor may include
a memory to store the desired dose or dosage information. In such
embodiments, the memory may include instructions to cause the processor
to receive gas delivery information or information regarding the amount
of gas delivered and compare the gas delivery information to the dosage
information and emit an alarm when the gas delivery information and the
dosage information match. As used herein, the term "dosage information"
may be expressed in units of parts per million (ppm), milligrams of the
drug per kilograms of the patient (mg/kg), millimeters per breath, and
other units known for measuring and administering a dose. In one or more
embodiments, the dosage information may include various dosage regimes
which may include administering a standard or constant concentration of
gas to the patient, administering a gas using a pulsed method. Such
pulsing methods includes a method of administering a therapy gas to a
patient during an inspiratory cycle of the patient, where the gas is
administered over a single breath or over a plurality of breaths and is
delivery independent of the respiratory pattern of the patient.

[0016] A fourth aspect of the present invention pertains to a method for
administering a therapy gas to a patient. The therapy gas may comprise
NO. In one or more embodiments, the method includes establishing
communication between the patient and a gas delivery device via a
transceiver, wherein the gas delivery device comprises a first memory
including gas data, comparing the gas data with patient information
stored within a second memory. The second memory may be included within a
control module in communication with the gas delivery device. After
comparing the gas data and the patient information, the method may
further include coordinating delivery of therapy to a patient with the
gas delivery device via a wireless optical line-of-sight signal,
selecting a therapy for delivery to the patient based on the comparison
of the gas data and the patient information and controlling delivery of
the selected therapy to the patient. In one or more specific embodiments,
the method may include entering the gas data into the first memory of the
gas delivery device and/or entering the patient information into the
second memory. In embodiments in which the method includes entering the
patient information into the second memory, the control module may
include input means by which patient information may be entered into the
second memory. In one or more variants, the method includes ceasing
delivery of the selected therapy to the patient based on the comparison
of the gas data and the patient information. The method may include
emitting an alert based on the comparison of the gas data and the patient
information.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 is a diagram of a gas delivery system including a gas
delivery device, a gas source, a control module and a gas delivery
mechanism, according to one or more embodiments;

[0018] FIG. 2 illustrates a valve assembly of the gas delivery device
according to one or more embodiments attached to a gas source;

[0020] FIG. 4 is a diagram showing a circuit supported in the valve
assembly shown in FIG. 2, according to one or more embodiments;

[0021] FIG. 5 illustrates an exemplary gas source for use with the valve
assembly shown in FIG. 2;

[0022] FIG. 6 is an operational flow diagram of the communication between
the circuit of the gas delivery device shown in FIG. 1 with a control
module regarding the establishment of communication between the circuit
and the control module

[0024] FIG. 8 illustrates a back view of the gas delivery system shown in
FIG. 7;

[0025] FIG. 9 illustrates a partial side view of the gas delivery system
shown in FIG. 7;

[0026] FIG. 10 illustrates a front view of a control module according to
one or more embodiments;

[0027] FIG. 11 illustrates a back view of the control module shown in FIG.
10;

[0028] FIG. 12 is an operational flow diagram of the communication between
the circuit of the gas delivery device and the control module shown in
FIG. 1 regarding the gas contained within a gas source; and

[0029] FIG. 13 is an operational flow diagram of the preparation of a gas
delivery device and use within the gas delivery system according to one
or more embodiments.

DETAILED DESCRIPTION

[0030] Before describing several exemplary embodiments of the invention,
it is to be understood that the invention is not limited to the details
of construction or process steps set forth in the following description.
The invention is capable of other embodiments and of being practiced or
being carried out in various ways.

[0031] A system for the administration of therapy gas is described. A
first aspect of the present invention pertains to a gas delivery device.
The gas delivery device may include a valve assembly including at least
one valve with a circuit. The gas delivery system may include the gas
delivery device (e.g. valve assembly, including a valve and a circuit) in
communication with a control module to control the delivery of gas from a
gas source to a ventilator or other device used to introduce the gas into
the patient, for example, a nasal cannula, endotracheal tube, face mask
or the like. Gas source, as used herein, may include a gas source, gas
tank or other pressured vessel used to store gases at above atmospheric
pressure. The gas delivery system 10 is shown in FIG. 1. In FIG. 1, the
valve assembly 100, including a valve 107 or valve actuator and a circuit
150, is in communication with a control module 200 via a wireless
line-of-sight connection 300. In one or more alternative embodiments,
communication between the valve assembly 100 and the control module 200
may be established via a wired signal. The gas delivery system 10 also
includes a gas source 50 including a gas attached to the valve assembly
100 and a gas delivery mechanism, which includes a ventilator 400 and a
breathing circuit 410, in communication with the control module 200.

[0032] FIGS. 2-4 illustrate the components of the valve assembly 100. The
valve assembly 100 includes a valve 107 and a circuit 150 supported in
the valve assembly. FIG. 3 illustrates a disassembled view of the valve
assembly 100, showing components of the physical circuit 150 and the
valve 107. As shown in FIG. 4, which will be described in more detail
below, the circuit 150 of the gas delivery device includes a valve
transceiver 120 for establishing communication with the control module
200, which will also be discussed in greater detail below.

[0033] Referring to FIG. 2, the valve 107 includes an attachment portion
102 for attaching the valve assembly 100 to the gas source 50, an inlet
104 and an outlet 106 in fluid communication with the inlet 104, as more
clearly shown in FIG. 2.

[0034] FIG. 3 illustrates a disassembled view of the valve assembly 100
and illustrates an actuator 114 is disposed on the valve 107 and is
rotatable around the valve 107 for opening and closing the valve 107. The
actuator 114 includes a cap 112 mounted thereto. As shown in FIG. 3, the
circuit 150 may include a data input 108 disposed on the actuator 114.
The data input 108 may be disposed at other locations on the valve 107.
In one or more variants, the data input may include a port such as a USB
port, a receiver for receiving electronic signals from a transmitted or
other known input means known in the art for entering information or data
into a memory.

[0035] FIG. 4 illustrates a block diagram of the circuit 150. The circuit
150 shown in FIG. 4 includes a valve processor 122, a valve memory 134, a
reset 128, a valve transceiver 120 and a power source 130. The circuit
150 may also include support circuits a timer 124, a sensor 126 and/or
other sensors. Referring to FIG. 3, the circuit 150 is supported within
the valve assembly 100, with the physical components of the circuit 150
specifically disposed between actuator 114 and the cap 112. As shown in
FIG. 3, the valve display 132 and the valve transceiver 120 are disposed
adjacent to the cap 112, such that the valve display 132 is visible
through a window 113. The sensor 126 and the valve processor 122 are
disposed beneath the valve display 132 and the valve transceiver 120,
within the actuator 114.

[0036] The valve processor 122 may be one of any form of computer
processor that can be used in an industrial setting for controlling
various actions and sub-processors. The valve memory 134, or
computer-readable medium, may be one or more of readily available memory
such as electrically erasable programmable read only memory (EEPROM),
random access memory (RAM), read only memory (ROM), floppy disk, hard
disk, or any other form of digital storage, local or remote, and is
typically coupled to the valve processor 122. The support circuits may be
coupled to the valve processor 122 for supporting the circuit 150 in a
conventional manner. These circuits include cache, power supplies, clock
circuits, input/output circuitry, subsystems, and the like.

[0037] In the embodiment shown, the valve memory 134 communicates with a
data input 108 disposed on the side of the actuator 114. The data input
108 shown in FIGS. 3-4 is used to transfer data from the valve memory 134
to other devices or to input data into the valve memory 134. For example,
gas data, which includes information regarding the gas contained within
the gas source, may be entered into the valve memory 134 via the data
input 108. In one or more alternative embodiments, the gas data may be
programmed or directly entered into the valve memory 134 by the gas
supplier. In one or more embodiments, the gas data may be provided in the
form of a bar code 610 that is disposed on a label 600 that is affixed on
a to the side of the gas source, as shown in FIG. 5. The bar code 610 may
be disposed directly on the gas source. An external scanning device in
communication with the electronic data input 108 may be provided and may
be used to scan the bar code 610 and convey the information from the bar
code 610 to the valve memory 134. Gas data may include information
regarding the gas composition (e.g., NO, O2, NO2, CO, etc.),
concentration, expiration date, batch and lot number, date of
manufacturing and other information. Gas data may be configured to
include one or more types of information. The valve processor 122 may
include instructions to convey all or a pre-determined portion of the gas
data via the valve transceiver 120 to another transceiver.

[0038] In embodiments that utilize a timer 124, the timer 124 may include
two sub-timers, one of which is a calendar timer and the other of which
is an event timer. The reset 128 may be located inside the actuator 114
and may be depressed to reset the event timer. The cap 112 also includes
a window 113 that allows the user to see the valve display 132 disposed
within the cap 112 that displays information regarding whether the
actuator 114 is opened or closed and the duration the valve 107 was
opened or closed. In one or more embodiments, the valve display 132 may
alternate flashing of two different numbers, a first number may be
accumulated open time, and the second number may be the time at which the
valve 107 was opened for the current event. The time at which the valve
107 was opened for a current event may be preceded by other indicators.

[0039] The sensor 126 disposed within the actuator 114 may include a
proximity switch model MK20-B-100-W manufactured by Meder Inc. The sensor
126 utilized in one or more embodiments may cooperate with a magnet (not
shown) to sense whether the actuator 114 is turned on or turned off. Such
sensors are described in U.S. Pat. No. 7,114,510, which is incorporated
by reference in its entirety.

[0040] For example, the sensor 126 and a corresponding magnet (not shown)
may be disposed on a stationary portion of the valve 107. When the
actuator 114 is rotated to the closed position, the sensor 126 is
adjacent to the magnet that is in a fixed position on the valve 107. When
the sensor 126 is adjacent to the magnet, it sends no signal to the valve
processor 122, thereby indicating that the actuator 114 is in the
"closed" position or has a valve status that includes an open position or
a closed position. When the actuator 114 is rotated to open the valve
107, the sensor 126 senses that it has been moved away from the magnet
and sends a signal to the valve processor 122, indicating an "open"
position. The valve processor 122 instructs the valve memory 134 to
record the event of opening the valve 107 and to record the time and date
of the event as indicated by the calendar timer. The valve processor 122
instructs the valve memory 134 to continue checking the position of the
valve 107 as long as the valve 107 is open. When the valve 107 is closed,
the valve processor 122 uses the logged open and close times to calculate
the amount of time the valve 107 was open and instructs the valve memory
134 to record that duration and the accumulated open time duration. Thus,
every time the valve 107 is opened, the time and date of the event is
recorded, the closing time and date is recorded, the duration of time
during which the valve 107 is open is calculated and recorded, and the
accumulated open time is calculated and recorded.

[0041] In one or more embodiments in which the power source 130 includes a
battery, the valve transceiver 120 may be configured to communicate with
the CPU transceiver 220 to preserve the life of the battery. In this
embodiment the valve transceiver 120 is only turned on to receive a
signal from the Control Module CPU transceiver 220 for 20 msec every
second. The control module CPU transceiver 220 sends out a short transmit
signal continuously and if the valve transceiver 120 is present it
responds in the 20 msec interval. This conserves battery power as the
valve transceiver 120 is only powered on for 20 msec every second. When
the valve transceiver 120 responds it includes in its signal information
regarding whether the communication from the control module CPU
transceiver 220 was early or late within this 20 msec window. This
ensures that once communications has been established it is synchronized
with the 20 msec window that the valve transceiver 120 is powered on and
able to receive communications. For example, as shown in FIG. 6, the
valve transceiver 120 sends a wireless optical line-of-sight signal
during a pre-determined interval in response to a signal from the control
module CPU transceiver 220. The wireless optical line-of-sight signals
sent by the valve transceiver 120 are a series of on off cycles where the
transmitter is either transmitting light or is not and these correspond
to digital binary signals. The mechanism by which the valve transceiver
sends a wireless optical line-of-sight signal may be construed as a
series of digital on off signals that correspond to data being
transmitted. Once communications has been established between the control
module CPU transceiver 220 and the valve transceiver 120, the interval
between communication signals may be in the range from about 20 seconds
to about 5 seconds. In one or more specific embodiments, the interval or
duration between transceiver signals may be about 10 seconds.

[0042] As will be described in more detail below, the control module 200
includes a CPU 210 which is connected to a CPU transceiver 220 which can
send and receive wireless optical line-of-sight signals. The CPU
transceiver 220 sends out a signal and waits for a response from the
valve transceiver 120 when communication or more specifically,
line-of-sight communication is established between the CPU transceiver
220 and the valve transceiver 120. If no response is sent by the valve
transceiver 120, the CPU transceiver 220 sends another signal after a
period of time. This configuration preserves battery life because the
valve transceiver 120 does not continuously send a signal unless
requested to by the CPU 210. This is important as the gas delivery device
and gas source spends most of its time in shipping and storage prior to
being placed on the gas delivery system, if it was transmitting all this
time trying to establish communications with the control module it would
be consuming the battery life significantly.

[0043] The valve processor 122 may include link maintenance instructions
to determine whether the interval should be increased or decreased. As
shown in FIG. 6, when a valid link is established between the valve
transceiver 120 and CPU transceiver 121, the valve processor 122 executes
the link maintenance instructions to increase the interval or decrease
the interval.

[0044] As shown more clearly in FIG. 1, valve assembly 100 and gas source
50 is in communication with a control module 200, which is in
communication with a gas delivery mechanism. The gas delivery mechanism
shown in FIG. 1 includes a ventilator 400 with associated breathing
circuit 410. The control module 200 may include a CPU 210 and a CPU
transceiver 220 in communication with the circuit 150 via the valve
transceiver 120. The control module 200 also includes a CPU memory 212 in
communication with the CPU transceiver 220 to store patient information,
information or data received from the valve transceiver 120 and other
information. The control module 200 may also include support circuits.
The CPU 210 may be one of any form of computer processor that can be used
in an industrial setting for controlling various actions and
sub-processors. The CPU memory 212, or computer-readable medium, may be
one or more of readily available memory such as random access memory
(RAM), read only memory (ROM), floppy disk, hard disk, or any other form
of digital storage, local or remote, and is typically coupled to the CPU
210. The support circuits may be coupled to the CPU 210 for supporting
the control module 200 in a conventional manner. These circuits include
cache, power supplies, clock circuits, input/output circuitry,
subsystems, and the like. The CPU 210 may also include a speaker 214 for
emitting alarms. Alternatively, alarms may also be displayed visually on
a display. As shown in FIG. 1, the control module 200 may also include a
regulator 110 and, optionally, pressure gauges and flow meters for
determining and/or controlling the gas flow from the gas source 50.

[0045] In one or more embodiments, the CPU transceiver 220 is disposed on
a cover portion 225 (shown more clearly in FIG. 7), that is part of a
cart 500 (show more clearly in FIG. 7) onto which the control module 200
is disposed. The cover portion 225 in one or more embodiments is in
communication with the control module 200. Communication between the
cover portion 225 and the control module 200 may be established
wirelessly or via a cable. As will be discussed in greater detail below,
the valve assembly 100, including the valve 107, the circuit 150 and a
gas source 50 attached to the valve 107, are placed on the cart 500 in
proximity and in a light-of-sight path with the CPU transceiver 220. When
properly configured such that communication is established between the
valve transceiver 120 and the CPU transceiver 220, the CPU transceiver
220 is positioned directly above the valve transceiver 120, as shown more
clearly in FIG. 9. In one or more alternative embodiments, the CPU
transceiver 220 may be disposed on the CPU 210.

[0046] The CPU 210 may be in communication with a plurality of gas sensors
230 for determining the concentration of a sample of gas drawn via a
sample line 232 and a sample line inlet 280 (shown more clearly in FIG.
1) disposed on the control module 200. As will be discussed in greater
detail, the sample line 232 draws a sample of gas from a breathing
circuit 410 of a ventilator 400 when the ventilator is in fluid
communication with the control module 200 and gas is being delivered to
the ventilator. The CPU 210 may also be in communication with a sample
flow sensor 234 for sensing the flow of the sample drawn via sample line
232, a pump 236 for drawing the sample via the sample line 232 to the
flow sensor 234 and zero valve 238 controlling the flow of the sample via
the sample line 232 to the sample pump 236, sample flow sensor 234 and
the plurality of CPU sensors. The sample line 232 may include a water
trap 233 for collecting any water or liquid from the sample.

[0047] The control module 200 may also include a delivery module 260 for
regulating the flow of gas from the gas source 50 to the ventilator 400.
The delivery module 260 may include a pressure switch 262 for determining
a gas supply pressure is present, a pressure shut-off valve 264, a
proportional valve 266 and a delivery flow sensor 268. The delivery
module 260 may also include a backup on/off switch 269. The detailed
method of how the delivery module delivers the gas to the ventilator
circuit is described in U.S. Pat. No. 5,558,083 which is incorporated
here by reference in its entirety.

[0048] The ventilator 400 shown in FIG. 1 is in fluid communication with
the control module 200 via an injector tubing 440 and in electrical
communication via an injector module cable 450. The control module 200
and more specifically, the CPU 210, is in fluid communication with the
ventilator 400 via the sample line 232. The ventilator 400 may include a
breathing circuit 410 with an inspiratory limb 412 and an expiratory limb
414 in fluid communication with the ventilator 400. The inspiratory limb
412 may be in fluid communication with a humidifier 420, which is in
fluid communication with the ventilator 400 via an injector module 430.
The inspiratory limb 412 carries gas to the patient and the expiratory
limb 414 carries gas exhaled by the patient to the ventilator 400. The
injector module 430 shown in FIG. 1 is in fluid communication with the
gas source 50 via the injector tubing 440 and in electronic communication
with the delivery module 260 via the injector module cable 450 such that
the delivery module 260 can detect and regulate the flow of gas from the
gas source 50 to the ventilator 400. Specifically, the injector module
430 is in fluid communication with the gas source 50 via an injector
tubing 440, which is in fluid communication with one or more of the
pressure switch 262, pressure shut-off valve 246, proportional valve 266,
flow sensor 268 and the backup switch 269 of the delivery module 260. The
injector module 430 may also be in electronic communication with the
delivery module 260 via the injector module cable 450. The inspiratory
limb 412 of the ventilator 400 may include a sample tee 416 for
facilitating fluid communication between the inspiratory limb 412 of the
breathing circuit and the sample line 232.

[0049] As discussed above, the control module 200 may be disposed or
attached on a cart 500, as shown in FIGS. 7-9 to facilitate movement of
the gas source 50 and the gas delivery device to a patient in need of gas
therapy. The gas source 50 and the valve assembly 100 attached thereto
may be placed on the cart 500 in proximity to the control module 200.
More specifically, as shown in FIG. 7, the gas source 50 is placed on the
cart 500 such that the valve transceiver 120 is in proximity of the CPU
transceiver 220 and a line-of-sight path is established between the valve
transceiver 120 and the CPU transceiver 220. In this configuration, the
CPU 210 detects the presence of the circuit 150 and thus the gas source
50 via the CPU transceiver 220.

[0050] As shown in FIGS. 7-9, the gas delivery device may include more
than one valve, with each valve being attached to a single gas source. In
such embodiments which utilize a second gas source 60 with a second valve
assembly 101, the second valve assembly 101 is positioned in proximity
and in a light-of-sight path with a second CPU transceiver as the gas
source 60 is loaded onto the cart. The second CPU transceiver 222
establishes communication with the second valve assembly 101 and thus
detects the presence of a second gas source 60. In the embodiment shown
in FIGS. 7-9, the second CPU transceiver 222 may also be disposed on the
cover portion 225 of a cart. In one or more alternative embodiments, the
second CPU transceiver 222 may be disposed on the CPU 210.

[0051] As shown in FIG. 8, the cart 500 may include an optional small bin
510, a mount 512 for supporting the control module 200 on the cart 500,
at least one a holding bracket 520, at least one mounting strap 530, an
auxiliary bracket 540, for holding an auxiliary gas source, a plurality
of casters 550 and a caster lock lever 560 disposed on each of the
plurality of casters 550. The cart 500 may include a mount 570 for
mounting the control module 200 on to the cart.

[0052] An exemplary control module 200 is shown in FIGS. 10-12 includes a
display 270 for providing visual indication to the user the components of
the gas being delivered from the gas source 50 to the ventilator 400
(e.g., NO, O2, NO2), the concentration of each component and
whether communication has been established with one or more gas sources.
Other information may also be displayed to the user. In addition, visual
alarms may also be displayed on the display 270. The control module 200
may also include a main power indicator 272 indicating whether the
control module is connected to a power source, such as an AC/DC power
source and/or a battery. The control module 200 may also include a
control wheel 274 allowing the user to navigate through various displays
or information displayed on the display. An injection module tubing
outlet 276 may be disposed on the control module for providing fluid
communication between the delivery module 260 and the injector module
430. An injection module cable port 278 may also be provided on the
control module to provide electronic communication between the delivery
module 260 and the injector module 430. The control module 200 shown in
FIGS. 10-12 also includes the sample line inlet 280 in fluid
communication with the sample line 232 and the inspiratory limb 412 of
the ventilator 400. In the embodiment shown in FIGS. 10-12, the water
trap 233 is disposed on the control module, adjacent to the sample line
inlet 280.

[0053] FIG. 11 illustrates a back view of the control module 200 and shows
a plurality of inlets. In the embodiment shown, two gas inlets 282, 284
for connecting the control module 200 to the gas source 50 are provided
and one auxiliary inlet 286 for connecting the control module 200 to an
auxiliary gas source, which may include oxygen or other gas. A power port
288 is also provided on the back of the control module to connect the
control module to an AC/DC power source.

[0054] The control module 200 may also include an input means 290 for
allowing the user to enter patient information, for example the identity
of the patient, the type and concentration of the gas and dose of the gas
to be administered to the patient, the patient's disease or condition to
be treated by the gas or reason for treatment, gestational age of the
patient and patient weight. The input means 290 shown in FIG. 12 includes
a keyboard integrated with the display. In one or more alternative
embodiments, the input means may include a USB port or other port for the
connection of an external keyboard or other input mechanism known in the
art. The information entered via the input means 290 is stored within the
CPU memory 212.

[0055] The control module 200 and the valve assembly 100 may be utilized
in the gas delivery system 10 to improve patient safety. Specifically,
the safety benefits of the gas delivery system described herein include
detecting a non-confirming drug or gas source, an expired drug or gas,
incorrect gas type, incorrect gas concentration and the like. In
addition, embodiments of the gas delivery system described herein also
improve efficiency of gas therapy.

[0056] FIG. 13 is a block diagram showing the sequence of how gas delivery
device, including the valve assembly 100, may be provided and its use
within the gas delivery system 10, according to one or more embodiments.
As shown in FIG. 13, the gas delivery device 10 is prepared for use by
providing a gas source 50 in the form of a gas cylinder or other
container for holding a gas and filling the gas source 50 with a gas
(700) and attaching a valve assembly 100 as described herein, to assemble
the gas delivery device 10 (710). These steps may be performed by a gas
supplier or manufacturer. The gas data regarding the gas filled within
the gas source 50 is entered into the valve memory 134 as described
herein (720). The gas data may be entered into the valve memory 134 by
the gas supplier or manufacturer that provides the gas source 50 and
assembles the gas delivery device 10. Alternatively, the hospital or
other medical facility may enter the gas data into the valve memory 134
after the gas delivery device has been transported to the hospital or
medical facility (730). The gas delivery device 10 is positioned on a
cart 500 (740) and communication between the CPU transceiver 220 and the
valve transceiver 120 is established (750). The gas data stored within
the valve memory 134 is conveyed to the control module 200 (760) via the
wireless optical line-of-sight communication between valve transceiver
120 and the CPU transceiver 220. The CPU 210 compares the gas data to
patient information entered into the CPU memory 212 (770). The patient
information may be entered into the CPU memory after the gas data is
entered into the CPU memory 212. The patient information may be entered
into the CPU memory before the gas delivery device 10 is positioned in
the cart or before communication between the CPU transceiver 220 and the
valve transceiver is established. In one or more alternative embodiments,
the patient information may be entered into the CPU memory 212 before the
gas delivery device 10 is prepared or transported to the hospital or
facility. The CPU 210 then compares whether the gas data and the patient
information match (780). If the gas data and the patient information
match, then gas is administered to the patient (790), for example through
a ventilator or other gas delivery mechanism. If the gas data and the
patient information do not match, then an alarm is emitted (800). As
described otherwise herein, the alarm may be audible and emitted through
the speaker 214 and/or may be visual and displayed on the display 270.

[0057] The gas delivery system described herein simplifies set-up
procedures by utilizing wireless line-of-sight signals to establish
communication. The user does not need to ensure all the cables are
correct connected and can freely load new gas sources onto a cart without
disconnecting cables linking the control module 200 and the valve
assembly 100 or circuit 150. This reduces set-up time and any time spent
correcting errors that may have occurred during the set-up process. The
control module 200 and the circuit 150 are further designed to
automatically send and detect information to establish delivery of a
correct gas having the correct concentration and that is not expired. In
one or more specific embodiments, such automated actions prevent the use
of the gas delivery system by preventing gas flow to a patient, without
user intervention.

[0058] In one or more embodiments, after communication between the valve
transceiver 120 and the CPU transceiver 220 is established, the valve
processor 122 includes instructions to convey the gas data stored in the
valve memory 134 via the valve transceiver 120 to the CPU transceiver
220. The CPU 210 includes instructions to store the gas data received
from the CPU transceiver 220 in the CPU memory. The CPU 210 also includes
an algorithm that compares the gas data with patient information that is
entered into the CPU memory 212. If the gas data and the patient
information do not match, the CPU 210 includes instructions to emit an
alarm, which may be audible, visual or both, alerting the user that the
gas contained within the gas source is different from the gas to be
administered to the patient. For example, as illustrated in FIG. 12, if
the gas data includes gas expiration date, the CPU memory 212 includes
information regarding the current date and the CPU 210 compares the gas
expiration date with the current date. If the gas expiration date is
earlier than the current date, the CPU 210 emits an alarm. The alarm may
be emitted through one or both the speaker 214 and display 270. In one or
more embodiments, the CPU 210 may include instructions that the delivery
module 260 cease or prevent delivery of the gas. In one or more
embodiments, the CPU 210 includes instructions to turn the backup on/off
switch 269 off if the delivery module 260 commences or continues delivery
of the gas. The detection of an expired gas by the CPU 210 may be stored
within the CPU memory 212.

[0059] If the gas data includes gas concentration information or data, the
CPU memory 212 includes information regarding the desired concentration
of gas to be administered to the patient. The control module 200 may be
configured to alert the user that the gas contained within a gas source
has incorrect concentration or a concentration that does not match the
desired gas concentration. For example, a user may enter a concentration
of 800 ppm into the CPU memory 212 and this concentration is compared to
the gas concentration conveyed from the valve memory 134 to the CPU
memory 212. As illustrated in FIG. 12, the CPU 210 includes instructions
to compare the gas concentration of the gas with the concentration
entered by the user. If the gas concentration does not match the
concentration entered by the user, the CPU 210 emits an alarm, which may
be audible and/or visual. In one or more embodiments, the CPU 210 may
include instructions that the delivery module 260 cease or prevent
delivery of the gas. In one or more embodiments, the CPU 210 includes
instructions to turn the backup on/off switch 269 off if the delivery
module 260 commences or continues delivery of the gas. The detection of a
gas with incorrect concentration may be stored within the CPU memory 212.

[0060] In one or more embodiments, the control module 200 may be
configured to detect more than one valve and to detect whether more than
one valve is turned on. This configuration eliminates waste because it
alerts a user that both valves are turned on and thus unnecessary gas is
being delivered to via the delivery module 260. In addition, such a
configuration improves safety because it avoids the issues related to
having two regulators pressurized at the same time and connected to the
delivery module 260. In one or more embodiments, the cover portion 225 of
the control module 200 may include a second CPU transceiver 222 and the
CPU 210 may include instructions for the second CPU transceiver 222 to
detect wireless optical line-of-sight signals from a second valve
assembly 101, and more specifically, a second valve transceiver 121. The
CPU 210 may also include instructions that once a second valve assembly
101 is detected by the CPU transceiver 222, whether both valve assemblies
100, 101 are opened or have a valve status that includes an open
position. In operation, a first valve assembly 100 includes a circuit
with a valve processor with instructions to covey an open or closed
position via the first valve transceiver 120. The circuit of the second
valve assembly similarly includes a valve processor with instructions to
convey an open or closed position via a second valve transceiver 121. The
first CPU transceiver 220 and the second CPU transceiver 222 detect the
valve statuses for each respective valve assembly from the first valve
transceiver 120 and the second valve transceiver 121 via the wireless
optical line-of-sight signals sent by both transceivers. The CPU 210
instructs the CPU transceivers 220, 222 to collect the valve statuses for
both valve assemblies 100, 101 and the memory to store the valve
statuses. The CPU 210 then compares the valve status information from the
first valve assembly 100 and the second valve assembly 101 and, if the
valve statuses both comprise an open position, the CPU 210 emits an
alarm. The alarm may be audible and/or visual. In one or more
embodiments, the CPU 210 may include instructions that the delivery
module 260 cease or prevent further delivery of gas through either the
first valve assembly or the second valve assembly. In one or more
embodiments, the CPU 210 includes instructions to turn the backup on/off
switch 269 off if the delivery module 260 commences or continues delivery
of gas. The detection that more than one valve assembly had a valve that
was turned on or had a valve status including an open position may be
stored within the CPU memory.

[0061] In one or more embodiments, the control module 200 may be
configured to alert a user when the desired dose has been delivered. In
such embodiments, the patient information entered into the CPU memory 212
may include dosage information or the dose to be delivered to a patient.
The valve processor 122 may include instructions to convey gas usage
information from the valve memory 134, including the amount of gas
delivered, to the CPU memory 212 via the valve transceiver 120.
Alternatively, the valve processor 122 may include instructions to covey
the duration of time the valve 170 has been turned on or has a valve
status including an open position to the CPU memory 212 via the valve
transceiver 120. The CPU 210 may include instructions to compare the
dosage information entered by the user and stored within the CPU memory
212 with the gas usage information. The CPU 210 may include instructions
to emit an alarm when the dosage information and the gas usage
information match. The CPU 210 may include instructions to emit the same
or different alarm to alert the user to turn off the valve or, more
specifically, the actuator 114 when the dose has been delivered. In one
or more embodiments, the CPU 210 may include instructions that the
delivery module 260 cease or prevent further delivery of gas. In one or
more embodiments, the CPU 210 includes instructions to turn the backup
on/off switch 269 off if the delivery module 260 commences or continues
delivery of gas.

[0062] In addition, the control module 200 may be configured to alert the
user that a detected valve is and remains closed and no gas is being
delivered to the patient. This configuration expedites treatment time and
increases efficiency for the hospital. In such embodiments, the valve
processor 122 may include instructions for the valve transceiver 120 to
convey the valve status to the CPU 210 via a wireless optical
line-of-sight signal. The CPU 210 includes instructions to collect the
valve status information and emit an alert if the dosage information is
set or other input has been entered into the CPU memory 212 to commence
treatment and the valve status includes a closed position.

[0063] The control module 200 may be configured to alert the user that no
valve assembly or gas source has been detected. In such embodiments, the
CPU 210 includes instructions to detect the presence of a wireless
optical line-of-sight signal from another transceiver, for example, the
valve transceiver 120. The CPU 210 may include instructions to emit an
alarm if the dosage information or other input to commence delivery of
the gas has been entered into the CPU memory 212 and no signal from
another transceiver has been detected. Similarly, the control module 200
may be configured to emit an alarm if communication between one or both
of the CPU transceiver(s) 220, 222 and one or both of the valve
transceivers 120, 121 has been lost during gas delivery. In such
embodiments, the CPU 210 may include instructions to continuously detect
the presence of a signal from another transceiver and emit an alarm if
the dosage information or other input to commence delivery of the gas has
been entered into the CPU memory 212 and no signal from another
transceiver has been detected.

[0064] The CPU 210 may include instructions to alert a user when sensors
in the control module 200 must be calibrated to ensure accurate delivery
of gas to a patient. In addition, the CPU 210 may include instructions to
correlate gas usage information from the circuit 150 of the valve
assembly 100 to the patient information entered into the CPU memory 212.
The CPU 210 may also have instructions to store the correlated gas usage
information and the patient information in the CPU memory 212. The valve
processor 122 may also include instructions detect patient information
from the CPU memory 212. Specifically, the valve processor 122 may
include instructions to collect patient information via the valve
transceiver 120 from the CPU transceiver 220 and store the collected
patient information in the valve memory 134. In such embodiments in which
information from the CPU 210 is collected and stored in the valve memory
134, the CPU 210 may include instructions that the patient information
and/or correlated patient information and gas usage information be
conveyed from the CPU memory 212 via the CPU transceiver 220 to the valve
transceiver 120. The valve processor 122 may also include instructions to
correlate gas usage information with the collected patient information
and store the correlated gas usage information and collected patient
information in the valve memory 134. Alternatively, the valve processor
122 may include instructions to collect the correlated patient
information and gas usage information from the CPU 210. The correlated
information may be utilized to bill the user according to patient. In
addition, the correlated information may be utilized as patient
demographic data, which can assist hospitals or other facilities to
generate budget reports, determine usage per department, determine usage
per patient diagnosis and link usage of multiple gas sources to
individual patients.

[0065] In one or more embodiments, the gas used for treatment comprises
nitric oxide. Nitric oxide relaxes vascular smooth muscle and when
inhaled, nitric oxide selectively dilates the pulmonary vasculature, and
because of efficient scavenging by hemoglobin, has minimal effect on the
systemic vasculature. Accordingly, nitric oxide may be used to treat or
prevent pulmonary hypertension and/or hypoxic respiratory failure in a
patient by administering an effective amount of a gas comprising nitric
oxide. As used herein, a patient refers to a mammal at risk for
developing or diagnosed with the referenced disorder. According to one or
more embodiments, the patient is a human. In some embodiments, the
patient may be term or near-term neonate (i.e. >34 weeks).

[0066] Nitric oxide is commercially available as INOmax® from Ikaria,
Inc. INOmax® is currently indicated for the treatment of term and
near-term neonates with hypoxic respiratory failure associated with
clinical or echocardiological evidence of pulmonary hypertension.

[0067] The gas source may comprise a container having a gas comprising
nitric oxide. The nitric oxide may be stored in a carrier gas, such as
nitrogen, with a known concentration of nitric oxide. In some
embodiments, the nitric concentration in the container may be in the
range from 20 ppm to 10,000 ppm or from 100 ppm to 5000 ppm. Exemplary
nitric oxide storage concentrations include 100 ppm, 800 pm, 2440 ppm and
4880 ppm. The concentration of nitric oxide delivered to the patient's
lungs may vary depending on the patient or the condition treated, but
generally may be in the range from 5 ppm to 100 ppm for preventing or
treating various forms of pulmonary hypertension and/or hypoxic
respiratory failure. In one or more embodiments, the nitric oxide is
delivered at a concentration of about 20 ppm. In some embodiments where
the condition being treated or prevented is hypoxic respiratory failure,
the nitric oxide concentration may be delivered at a dose of about 20
ppm.

[0068] A second aspect of the present invention pertains to a method for
administering a therapy gas to a patient. The method includes providing a
gas in a gas source. The gas source may be prepared by a supplier to
contain a gas having a predetermined composition, concentration and
expiration date. The method may include providing a valve assembly 100
attached to a gas source 50 to dispense the gas contained within the gas
source 50 to a patient. The method may include entering gas data, which
may include gas composition, gas concentration and gas expiration date,
into the valve memory 134. In one or more embodiments, the supplier may
enter the gas data directly into the valve memory 134. In another
variant, the gas data is provided in the form of a bar code disposed on
the gas source. In such embodiments, the method includes providing a
scanner in communication with the data input 108, scanning the bar code
to collect the gas data information and conveying the gas data to the
valve memory 134 via the data input 108. These steps may be repeated for
a second gas source. The gas source(s), with the valve assembly mounted
thereon may be transported to a hospital or other facility for
administration to a patient. The gas source(s) are then mounted onto the
cart 500 and secured by the holding bracket 520 and mounting strap 530.
The method includes establishing communication between the valve
transceivers disposed on each valve and the CPU transceivers 220, 222.
Establishing communication may include positioning the valve assembly 100
in a line-of-sight path with at least one of the CPU transceivers 220,
222. As otherwise described herein, communication may be established by
instructing the valve transceivers to send a wireless optical
line-of-sight signal to the CPU transceivers 220, 222. The method may
include instructing the valve transceiver 120 to send a wireless optical
line-of-sight signal at pre-determined intervals, as otherwise described
herein.

[0069] The method may include entering patient information into the CPU
memory 212. This step may be performed before or after the gas source(s)
are mounted onto the cart. The method may specifically include entering
patient information such as dosage information into the valve memory 134.
The method includes coordinating delivery of the gas to the patient by
collecting gas data from the valve memory 134 and comparing the gas data
with the patient information according to an algorithm and determining if
the gas data and patient information match, according to the algorithm.
Coordinating delivery of the gas may include turning on the actuator 114
of the valve 107 such that gas can flow from the inlet 104 to the outlet
106. After the dose has been delivered, the method may include
correlating the gas usage information and the patient information. The
method may also include recording the patient information, gas usage
information and/or the correlated patient information and gas usage
information in the CPU memory 212 and/or the valve memory 134. In one or
more variants, the method may include utilizing the patient information,
gas usage information and/or correlated patient information and gas usage
information to generate invoices identifying the use of the gas by
individual patients.

[0070] Reference throughout this specification to "one embodiment,"
"certain embodiments," "one or more embodiments" or "an embodiment" means
that a particular feature, structure, material, or characteristic
described in connection with the embodiment is included in at least one
embodiment of the invention. Thus, the appearances of the phrases such as
"in one or more embodiments," "in certain embodiments," "in one
embodiment" or "in an embodiment" in various places throughout this
specification are not necessarily referring to the same embodiment of the
invention. Furthermore, the particular features, structures, materials,
or characteristics may be combined in any suitable manner in one or more
embodiments.

[0071] Although the invention herein has been described with reference to
particular embodiments, it is to be understood that these embodiments are
merely illustrative of the principles and applications of the present
invention. It will be apparent to those skilled in the art that various
modifications and variations can be made to the method and apparatus of
the present invention without departing from the spirit and scope of the
invention. Thus, it is intended that the present invention include
modifications and variations that are within the scope of the appended
claims and their equivalents.